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FDA Orders Bayer to Stop Sales of Aspirin Compounds

Says Two Products Make Unapproved Drug Claims

WASHINGTON (AdAge.com) -- Under pressure from congressional leaders, the Food and Drug Administration is telling Bayer Healthcare to pull over-the-counter drugs that combine aspirin with dietary supplements.
According to the FDA, the marketing of Bayer Aspirin With Heart Advantage and Bayer Women's Low Dose Aspirin With Calcium amounted to making drug claims for products never approved by the FDA as drugs.
In a letter today, the FDA said Bayer's marketing of Bayer Aspirin With Heart Advantage and Bayer Women's Low Dose Aspirin With Calcium amounted to making drug claims for products never approved as drugs. The women's product includes calcium with aspirin while Bayer Heart Advantage includes phytosterols with aspirin.

Drugs require certification
While calcium supplements are sometimes suggested for bone problems and phytosterols for fighting heart disease, the FDA said the only way the products could be marketed with aspirin would be if Bayer certified them as drugs and demonstrated their effectiveness.

"The FDA considers these products new drugs, and thus they must undergo the FDA's drug-approval process," said Mike Chappell, the FDA's acting associate commissioner for regulatory affairs. "The FDA will take enforcement action against manufacturers found to be violating the law or attempting to circumvent the drug approval process."

In a statement, the FDA said both products are labeled for use in reducing the risks of heart disease. Bayer Women's Low Dose Aspirin with Calcium is also labeled for use in "fighting" osteoporosis.

No diagnosis, no sale
"Neither product has been approved by the FDA for such uses. These drug uses require a health-care professional's diagnosis and supervision, and therefore these products cannot be labeled for use by consumers and sold over the counter," said the statement.

"Bayer is in the process of reviewing the letters and will respond to the FDA within the time frame outlined," said a company spokeswoman. "With regard to the marketing of Bayer Aspirin With Heart Advantage, which was launched earlier this year, and Bayer Women's Low Dose Aspirin With, which has been on the market since 2002, we stand behind both products and all marketing claims made in their support."

House criticism gets action
The FDA's action comes exactly two weeks after leaders of the House Energy and Commerce Committee complained to Bayer and the FDA about the marketing of the Bayer heart product.

In a letter dated Oct. 14, Energy and Commerce Chairman Rep. John Dingell, D-Mich., and Rep. Bart Stupak, D-Mich., chairman of the committee's oversight and investigations panel, questioned why the FDA was allowing the marketing of combination drugs like Bayer Heart Advantage.

The letter noted that in May 2000, the agency discouraged the marketing of combination products because the FDA doesn't generally determine the safety and effectiveness of dietary supplements.